RightFit
RecruitingPhase 1 / Phase 2

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of LTP001 in Healthy Adult Participants (Part A) and to Evaluate the Efficacy and Safety of LTP001 for the Treatment of Participants With Pulmonary Arterial Hypertension (Part B)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the treatment LTP001. Part A is for healthy people. Part B is for people with pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of the lungs.

A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Part A: Healthy males and females who cannot become pregnant.
  • Part A, Japanese groups: Must be first- through third-generation Japanese, as defined by the study rules.
  • Part B: Must have a confirmed diagnosis of PAH.
  • Part B: Before being assigned to a study group, resistance to blood flow in the lungs (PVR) must be at least 400 dyn.sec.cm-5.
  • Part B: Must be taking stable doses of usual PAH medicines.
  • Part B: Must be able to walk 150 to 450 meters in 6 minutes.

Who can't join

  • Part A: Serious heart problems or abnormal results on an ECG, a test of the heart's electrical activity.
  • Part A: A health condition or surgery that could greatly change how the body takes in, handles, or removes medicines, or make the study unsafe.
  • Part B: A health condition or surgery that could make taking part more risky.
  • Part B: Women who could become pregnant and are not using highly effective birth control.
  • Part B: Sexually active males who will not use a condom during sex while taking the study treatment and for 24 hours after stopping it.
  • Part B: A past allergic reaction to any study treatment or its ingredients.
  • Both parts: Other study rules may affect who can join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Part A Inclusion Criteria: * Healthy males and non-child-bearing potential females Part A Exclusion Criteria: * Clinically significant ECG or cardiac abnormalities, any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in the study Other protocol-defined inclusion/exclusion criteria may apply. * For Japanese cohorts: participants per protocol should be first generation Japanese or up to third generation Japanese as defined in inclusion criteria 7 of the protocol. Part B Inclusion Criteria: -Confirmed diagnosis of PAH, pre-randomization PVR ≥400 dyn.sec.cm-5, treatment with stable doses of standard-of-care PAH therapies, 6-minute walk distance ≥ 150 m and ≤450 m. Part B Exclusion Criteria: Any surgical or medical condition which may place the participant at higher risk from his/her participation in the study Women of child-bearing potential unless they are using highly effective methods of contraception Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 24 hours after stopping study treatment. History of hypersensitivity to any of the study treatments or excipients Other protocol-defined inclusion / exclusion criteria may apply

Study sites (20)

AZ

CA

CO

FL

GA

KS

KY

MA

MS

  • Sky Integrative Medical Center SKYCRNG PPDS · Ridgeland, MS 39157-5179Bob Hutchins · Principal investigatorMore trials in Ridgeland

OR

  • Summit Health Eastside Clinic · Bend, OR 97701Jeremy Feldman · Principal investigatorMore trials in Bend

PA

  • Allegheny General Hospital · Pittsburgh, PA 15212-4756Hayah Kassis-George · Principal investigatorMore trials in Pittsburgh

TN

TX

UT

VA